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NCT07053748Not yet recruiting

Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing Therapy

Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this observational study is to assess the safety and efficacy of trimodality bladder - sparing therapy in high - risk NMIBC patients. The main questions it aims to answer are: Is trimodality therapy safe and effective in the short term for high - risk NMIBC patients? What is its long - term effectiveness in terms of EFS, OS, and BI - EFS? How does it affect patients' QOL? Participants will be high - risk NMIBC patients receiving trimodality therapy at Peking University First Hospital. They will be observed to evaluate the therapy's effectiveness and impact on QOL using relevant assessment criteria and QOL scores.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
27 Jun 2025
Start date
30 Jun 2025
Primary completion date
30 Jun 2027
Lead sponsor
Peking University First Hospital
NCT number
NCT07053748

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 30 Jun 2025 to the primary completion date, 30 Jun 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe hepatic/renal dysfunction intolerance to chemoradiotherapy. Mental illness/cognitive impairment unable to comply with the study. Allergy to chemoradiotherapy drugs. Pregnant or breastfeeding women. Previous pelvic radiotherapy.

Other illness

  • Distant metastasis (M1). Other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).
  • Severe cardiovascular disease (uncontrolled heart failure, unstable angina, myocardial infarction, etc.).

Who the study is looking for

  • Histologically confirmed NMIBC (Ta Tis T1).
  • ≥2 recurrences after transurethral resection, or lack of response/intolerance to intravesical therapy (e.g., BCG).
  • Refusal of radical cystectomy and choice of TMT for bladder preservation. Aged ≥18 years. Signed informed consent. ECOG performance status of 0-2.
  • Adequate organ function for chemoradiotherapy:
  • Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L.
  • Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present).
  • Renal function: Creatinine clearance ≥30 mL/min (via Cockcroft-Gault formula).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.